Vice President, Head of Clinical Operations

Company Confidential - Greater Boston Area (Hybrid)

Full Time - Permanent 

Position Summary

A clinical-stage biotech company is seeking an experienced leader to serve as Vice President, Head of Clinical Operations. This individual will be responsible for building, developing, and leading a high-performing Clinical Operations organization, ensuring strategic oversight and execution of clinical programs within budget, timelines, and quality standards.

The ideal candidate will thrive in a fast-paced, collaborative environment, demonstrate exceptional leadership and analytical skills, and bring a strong track record of operational excellence in global clinical development.

Key Responsibilities

Provide strategic operational leadership to ensure all clinical programs are properly defined, planned, and executed to a high standard of quality.

Develop and implement vendor oversight processes, including documentation of regulatory responsibilities, performance evaluation, and issue escalation.

Build and evolve the Clinical Operations infrastructure, including team structure, systems, and processes.

Plan and manage department headcount and resourcing to meet program demands.

Establish and oversee clinical trial processes, strategic outsourcing, and key performance indicators.

Ensure compliance with company SOPs, ICH-GCP guidelines, and regulatory requirements to uphold the highest standards of patient safety and data integrity.

Lead budget planning, forecasting, and tracking for ongoing clinical studies.

Author and maintain Clinical Operations SOPs and related documentation.

Recruit, mentor, and develop Clinical Operations staff.

Provide input on lifecycle strategy, risk assessment, and mitigation planning across programs.

Collaborate cross-functionally on protocol development, safety reports, study reports, publications, and regulatory submissions.

Present regular clinical operations updates and strategic recommendations to executive leadership.

Qualifications

BS/BA in a scientific discipline with 15+ years of relevant Clinical Operations experience; MS or PhD with 12+ years considered.

Proven leadership experience building and managing Clinical Operations teams and overseeing global clinical programs.

Strong background in vendor/CRO management and resource optimization across multiple studies.

Hands-on experience with clinical trial management systems (TMF, EDC, IXRS).

In-depth understanding of FDA/EMA regulations, ICH-GCP, and global drug development practices.

Experience with rare disease programs preferred.

NDA/BLA submission experience a plus.

Excellent communication, presentation, and cross-functional collaboration skills.